NCIS
clinical trials
NCTN
drug indications
Association of National Cancer Institute-Sponsored Clinical Trial Network Group Studies With Guideline Care and New Drug Indications
Summary
- Importance: NCTN groups are vital in identifying effective new antineoplastic regimens, but their clinical impact has not been systematically evaluated until now.
- Objective: To determine the association of NCTN trials with guideline care and new drug indications.
- Design, Setting, and Participants: Retrospective cohort study of phase 3 SWOG Cancer Research Network trials (1980-2017) with published results. The study analyzed trials linked to NCCN guidelines or FDA drug approvals as practice influential (PI).
- Main Outcomes and Measures: Rate of PI trials and trends, along with federal investment supporting these trials.
- Results:
- 182 trials involving 148,028 patients were evaluated.
- 45.1% of trials (82) were PI.
- 38.5% influenced NCCN guidelines, 3.3% influenced FDA approvals, and 3.3% influenced both.
- Positive findings were in 72.3% of PI trials; 29.9% of negative-finding trials were also PI.
- 42.7% of PI trials were based on negative findings, often reaffirming standard care.
- Total federal investment: $1.36 billion, averaging $7.5 million per study or $16.6 million per PI trial.
- Conclusions and Relevance: Nearly half of phase 3 trials by a major NCTN group were linked to guideline care or new drug indications, showing both positive and negative findings. The federal funding investment is modest compared to pharmaceutical companies, providing cost-efficient evidence to guide patient care.
The National Cancer Institute (NCI) Clinical Trial Network (NCTN) groups serve a vital role in identifying new cancer treatments. Unlike pharmaceutical companies—whose primary aims are to develop new drugs and generate profits—the mandate of the NCTN is to serve the community of patients with cancer more broadly.
Network group trials may compare different treatment regimens, combine treatments and treatment modalities, and/or examine whether 1 or more newly approved drugs may work in other cancers. Although the network groups have been in existence since the 1950s, an examination of the clinical effects of network group trials as a research process has, to our knowledge, not been conducted to date.
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NCIS, clinical trials, NCTN, drug indications
